Inconvenience of administration and patient compliance are often significant concerns in connection with designing dosage forms for a variety of populations, including the elderly, children, and patients undergoing various treatments including, for example, chemotherapy. Difficulty swallowing, or dysphagia, is common among all patient populations, but often more prominent in the above-noted groups. For example, a high percentage of patients suffering from type-2 diabetes are elderly patients suffering from severe dysphagia. Subjects suffering from dysphagia may be choked or have a fear of being choked when taking a variety of dosage forms, including tablets, capsules, and viscous liquids. In view of the above, and various other considerations, many patients refuse to take required dosages or may require breakage of the dosage form. In addition to missing doses, breakage of dosage forms is undesired for a variety of reasons, including that the patient may not receive the required or recommended dose. Regardless of dysphagia or any fear of taking dosage forms or a fear of being choked, dosage forms that are more easily administered are desired for any patient or subject. For example, due to their ease in handling, the compositions of the present invention may be consumed as “on-the-go” by consumers while performing other activities. The visual and textural properties of the compositions of the present also make the compositions appealing to consumers, and particularly children. For example, the compositions of the present invention can be molded into a variety of shapes and/or a variety of colors may be incorporated that are appealing to children.
Dosage forms including one or more gelling agents are known in the art. However, many of these dosage forms suffer from one or more disadvantages. One disadvantage is formation of free water (i.e., un-gelled water) during storage, which is commonly referred to as syneresis. Formation of free, un-gelled water is undesired as it results in a change in the concentration of active ingredient and may also make the dosage form difficult to handle. Another disadvantage of many gelling agent-based dosage forms is thermal stability during storage. Many gelling agent-based dosage forms lose structural integrity during storage. In addition, certain gelling agent-based dosage forms may be difficult to consume (e.g., require significant chewing effort or pose a choking hazard) due to their insufficiently deformable structure provided by their gel strength.
For at least the foregoing reasons, there exists a need in the art for alternative gelling agent-based dosage forms that are more easily administered or taken and that also overcome one or more of the above-noted disadvantages associated with conventional gelling agent-based dosage forms.